ABPI - medicines for a healthy future
Yellow Card Scheme
25 October 2005
Improved system for people to report suspected side effects from their medicines to UK health watchdog
The Medicines and Healthcare products Regulatory Agency (MHRA) today launched a new UK-wide pilot to enable people to directly report their experiences of suspected side effects from medicines through its reporting system - the Yellow Card Scheme.
The improved system will see patient Yellow Card reporting forms being made available in pharmacies, GP surgeries and other NHS outlets across the UK from next week. Reports on suspected side effects can also be made on the Yellow Card website or by freephone to the Yellow Card hotline on 0808 100 3352.
The UK-wide pilot builds on the successful patient reporting pilot run from January which was restricted to certain parts of the UK, and the wide range of feedback provided from patients and carers in the development of mechanisms for reporting suspected side effects.
Professor Kent Woods, Chief Executive at the MHRA said, “I welcome the launch of this UK-wide pilot enabling people to report their suspected side effects to us. By inviting people to report their experiences, not only are we able to gain better insights into the safety of medicines, but we can more directly involve people in medicines regulation.”
Chairman of the Committee on Safety of Medicines (CSM), Professor Gordon Duff said, “The benefits of encouraging patients to complete Yellow Card reports are becoming evident. Patients provide a different and extremely useful insight into suspected side effects that we cannot easily get from Yellow Card reports from health professionals. The Yellow Card Scheme is vital in monitoring the safety of medicines in the UK, and the incorporation of patient reporting into the Yellow Card Scheme will have significant benefits, especially as the scheme evolves and patients become familiar with it. The contributions of the Committee on Safety of Medicines’ Patient Reporting Working Group have been extremely beneficial in helping to develop systems for patient reporting.”
Dr Patricia Wilkie, Chairman of the CSM’s Working Group on Patient Reporting said, “Patient reporting through the Yellow Card Scheme helps the MHRA to collect information on suspected side effects that patients have experienced, from the patient’s own perspective. The incorporation of the patient experience in the Yellow Card Scheme is essential for medicines safety monitoring, and will be important for the development of information for patients about their medicines. The launch of the UK-wide pilot is a major step forward in achieving real patient involvement".
1. This UK-wide pilot will test online reporting, the freephone
number and the patient forms to provide information on which to make
decisions about the implementation of the final patient reporting
2. Any member of the public can report suspected side effects
and reports can be made on others, for example by a parent or carer.
Reports can be made on prescribed medicines as well as those
available over-the-counter, and on complementary remedies (including
3. The MHRA welcomes Yellow Card reports on any suspected side effect.
It is especially useful for patients to report about:
a suspected side effect that is not mentioned in the patient
information leaflet that came with the medicine; or
a suspected side effect that has caused problems bad enough to
interfere with everyday activities
4. The MHRA launched initial patient reporting pilots, with patients
able to report suspected side effects to the MHRA either on a patient
Yellow Card, or via the Yellow Card website. The results of this
initial pilot were encouraging and have provided important feedback
for the development of the UK-wide pilot.
5. For over 40 years, the Yellow Card Scheme has been the cornerstone of
medicines safety monitoring in the UK. Since the Yellow Card scheme
was set up, over 500,000 reports of suspected side effects (known as
adverse drug reactions) have been completed, enabling the MHRA to
identify and take action on a wide range of previously unrecognised
medicines safety issues.
6. The Yellow Card Scheme was set up in 1964 following the Thalidomide
tragedy to provide a system for early detection of emerging drug
safety hazards, and the routine monitoring for all medicines in
clinical use. Suspected side effects from medicines are reported
through the Yellow Card Scheme to the MHRA and the Committee on
Safety of Medicines (CSM), which are jointly responsible for running
the scheme. Until this year, reports were received from healthcare
professionals, who report voluntarily. Reports of suspected side
effects are also received from pharmaceutical companies, who have a
legal obligation to report suspected serious side effects to the
7. The continued success of the Yellow Card scheme depends on the
continued support of health professionals and patients in completing
Yellow Cards. We encourage Yellow Card reports from patients who
suspect they have experienced a suspected ADR, but it is vitally
important that we also continue to receive reports from health
8. In 2004, the Government accepted recommendations made in the
Report of an Independent Review of Access to the Yellow Card Scheme
to extend Yellow Card reporting to patients.
9. The House of Commons Health Committee’s Report on the
Influence of the Pharmaceutical Industry (published on 5 April 2005)
recommended that a “system of patient reporting to the Yellow Card
Scheme country-wide be put in place as soon as possible”.
10. The Committee on Safety of Medicines (CSM) is an independent
committee of experts that advise the Government on the safety,
quality and efficacy of medicines. It is also responsible for
encouraging the collection and investigation of reports on suspected
side effects/adverse drug reactions to medicines available in the UK.
11. The Working Group on Patient Reporting is a working group of the
CSM set up by the MHRA to work specifically on the Yellow Card
Scheme. The working group has patient and consumer group, academic,
pharmacist and medical representatives. The terms of reference for
the working group are:
to advise the MHRA and CSM on the development of
different arrangements to pilot direct reporting by patients or
their carers of suspected adverse drug reactions (‘direct
to advise the MHRA and CSM on how best to communicate
to the public, patients, patient organisations and health
professionals about the pilot schemes;
to advise the MHRA and CSM on the initial and continued national evaluation of the direct patient reporting scheme;
and to recommend how best to develop patient
reporting nationally, and advise the MHRA and CSM on aspects of
communication on direct patient reporting.
12. The MHRA is the government agency responsible for ensuring that
medicines and medical devices work, and are acceptably safe. No
product is risk-free. Underpinning all our work lie robust and
fact-based judgements to ensure that the benefits to patients and the
public justify the risks. We keep watch over medicines and devices,
and take any necessary action to protect the public promptly if there
is a problem. We aim to make as much information as possible publicly
Head of Voluntary Sector Relations ABPI
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Email Marjorie Johnson
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